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FDA 510(k)

STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000

K-Number: K100852 · 2010-05-06

ApplicantStryker Communications
Decision Date2010-05-06
Product CodeOCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Communications. It received FDA 510(k) clearance on 2010-05-06 under 510(k) number K100852. The device is classified under product code OCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000?

STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 is a medical device that received FDA 510(k) clearance on 2010-05-06. The listed applicant is Stryker Communications. The 510(k) number is K100852.

When did STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 receive FDA 510(k) clearance?

STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 received FDA 510(k) clearance on 2010-05-06, under 510(k) number K100852.

Who is the listed applicant for STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000?

The FDA 510(k) record lists Stryker Communications as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000?

The FDA product code for STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 is OCS.

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Official Source

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